Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58)

This study is currently recruiting participants.
Verified February 2014 by AstraZeneca
Sponsor:
Collaborators:
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01730534
First received: November 15, 2012
Last updated: February 4, 2014
Last verified: February 2014

November 15, 2012
February 4, 2014
January 2013
April 2019   (final data collection date for primary outcome measure)
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01730534 on ClinicalTrials.gov Archive Site
  • Time to first event of Hospitalization for Congestive Heart Failure [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Body weight change from baseline [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes

This study is being carried out to see if dapagliflozin when added to a patients current anti-diabetes therapy is effective in reducing cardiovascular events such as myocardial infarction (MI) (heart attack), ischemic stroke, and cardiovascular (CV) related death, compared with placebo (inactive study medication).

Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Non-Insulin-Dependent
  • High Risk for Cardiovascular Event
  • Drug: Dapagliflozin 10 mg
    Oral dose (od)
  • Drug: Placebo tablet
    Oral dose (od)
  • Experimental: Dapagliflozin
    Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
    Intervention: Drug: Dapagliflozin 10 mg
  • Placebo Comparator: Placebo
    Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
    Intervention: Drug: Placebo tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22200
April 2019
April 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Female or male aged ≥40 years
  • Diagnosed with Type 2 Diabetes
  • High Risk for Cardiovascular events

Exclusion Criteria:

  • Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
  • Chronic cystitis and/or recurrent urinary tract infections
  • Pregnant or breast-feeding patients
Both
40 Years and older
No
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   Vietnam
 
NCT01730534
D1693C00001
Not Provided
AstraZeneca
AstraZeneca
  • Bristol-Myers Squibb
  • The TIMI Study Group
  • Hadassah Medical Organization
Study Director: Eva Johnsson, MD AstraZeneca Sweden
Study Chair: Marc S Sabatine, MD, MPH TIMI Study Group, Boston, MA, USA
Principal Investigator: Itamar Raz, MD Hadassah Medical Organization
Principal Investigator: Stephen D Wiviott, MD TIMI Study Group, MA, USA
AstraZeneca
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP